Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment [ Time Frame: Baseline and 76 weeks ] [ Designated as safety issue: No ]

Change from baseline in HbA1c after 76 weeks

Original Primary Outcome Measures ICMJE (submitted: February 3, 2011)

Changes from baseline in clinical laboratory values, changes from baseline of Albumin/creatinine ratio and use of rescue therapy after 52, 76 weeks of treatment and at end of trial [ Time Frame: Treatment period (minimum 76 weeks) ] [ Designated as safety issue: Yes ]

To assess efficacy of BI 10773 and for patients from 1245.20 sitagliptin for minimum 76 weeks compared to placebo as monotherapy or placebo on a background of pioglitazone or placebo on a background of metformin with or without sulfonylurea. [ Time Frame: Treatment period (minimum 76 weeks) ] [ Designated as safety issue: No ]

The HbA1c, body weight (kg), waist circumference and fasting plasma glucose changes from baseline after 52, 76 weeks of treatment and to end of trial [ Time Frame: Treatment period (minimum 76 weeks) ] [ Designated as safety issue: No ]

Systolic and diastolic blood pressure: Change from baseline after 52, 76 weeks of treatment and to end of trial For patients rolling over from 1245.20: - Change from baseline in biomarkers of insulin sensitivity and secretion to end of trial [ Time Frame: Treatment period (minimum 76 weeks) ] [ Designated as safety issue: No ]

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

Safety and Efficacy of Empagliflozin (BI 10773) and Sitagliptin Versus Placebo Over 76 Weeks in Patients With Type 2 Diabetes

Official Title ICMJE

A Phase III Double-blind, Extension, Placebo-controlled Parallel Group Safety and Efficacy Trial of BI 10773 (10 and 25mg Once Daily) and Sitagliptin (100mg Once Daily) Given for Minimum 76 Weeks (Incl. 24 Weeks of Preceding Trial) as Monotherapy or With Different Back-ground Therapies in Patients With Type 2 Diabetes Mellitus Previously Completing Trial 1245.19, 1245.20 or 1245.23

Brief Summary

This study will investigate the efficacy and long term safety and tolerability of BI 10773 in type 2 diabetic patients.

Contraindications to sitagliptin, pioglitazone, metformin or sulfonylurea according to local label, which started during trial participation in 1245.19, 1245.20 or 1245.23

Pre-menopausal women (last menstruation < or = 1 year prior to informed consent) who are nursing or pregnant or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems, oral, implantable or injectable contraceptives, sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner.

Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake.

Participation in another trial with an investigational drug within 30 days prior to informed consent (except 1245.19, 1245.20 and 1245.23).

Any other clinical condition that would jeopardize patient's safety while participating in this clinical trial.

Gender

Both

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects